142 results
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Sources: EU EUDAMED, US FDA
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Country: Sweden
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XVIVO Organ Chamber REF 19020
FDA Enforcement
Class II
·Terminated·XVIVO PERFUSION AB·June 8, 2022
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
FDA Enforcement
Class II
·Terminated·HemoCue AB·November 6, 2013
HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
FDA Enforcement
Class II
·Terminated·HemoCue AB·November 6, 2013
Iodine Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
IBS Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Candida Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Akkermansia Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Neurotransmitters XL
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Neurotransmitters Basic
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
SIBO Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Parasite Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Neurotransmitters Plus
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Melatonin Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
PSA Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
DHEA Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Serotonin Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Lactose Intolerance Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Mycotoxin Panel Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Fructose Intolerance Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Intestinal Worms Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025